Prospective randomized comparative study of therapeutic efficacy of microneedling with 5-fluorouracil 5% cream versus topical 88% phenol application in the treatment of vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Compare the clinical response by repigmentation to microneedling with 5-fluorouracil 5% cream and topical 88% phenol application in the treatment of vitiligo
研究概览
简要总结
After applying inclusion and exclusion criteria .History and written consent from the patient is taken. Topical anesthesia will be applied over lesions .
For Group A patients A layer of 5-FU cream 5% will be applied over the lesions. Microneedling will be done with DermaPen using the lowest speed with needle penetration depth. After cleaning with betadine, equal quantities of 5-FU cream 5% and fusidic acid cream 2% were applied The procedure will be repeated every 2 weeks for 6 sessions and followed up at monthly intervals for next 3 months
For Group B Patients Topical 88% phenol will applied once gently with uniform smooth strokes to cover the entire lesion till an ivory white uniform frosting appeared. Prophylactic antibiotic cream will be applied twice in a day till the lesions healed Patients followed up at every 2 weeks for 3 months and at monthly intervals for next 3 month
Clinical improvement and side effects will be assessed after each session
.T The study will be concluded with the comparison of clinical improvement of both group A and group B study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with clinical diagnosis of stable vitiligo Patients who are willing to participate in the study.
排除标准
- •Patients with unstable vitiligo Patients allergic to 5-fluorouracil 5% cream and 88% phenol Patients with predisposition to keloids Patients and lactating mothers Patients not willing for procedures.
结局指标
主要结局
Compare the clinical response by repigmentation to microneedling with 5-fluorouracil 5% cream and topical 88% phenol application in the treatment of vitiligo
时间窗: At the end of 3 months, and 6 months
次要结局
- Treatment side effects(Every 4 weeks for 3 months)